In comparison to batch manufacturing, continuous manufacturing offers shorter development time, improved and uniform product quality, lower capital cost, and easy scale-ups. The primary focus, thereby, lies on establishing a flexible and standard platform with real-time monitoring, automated start-up/shut down, and a control strategy to address the dynamically changing conditions.
- Can Real-World Evidence Transform Healthcare? FDA Activities Indicate Yes
- Why Do We Outsource To China?
- Inflation Sticks, Supply Chains Stall, Outsourcing A Struggle
- Solving The 4 Serialization Challenges Of Track & Trace In The Biopharma Industry
- Demystifying Blockchain-Supported Smart Contracts
- Small Acquisition Leads To Critical Analysis Of Outsourcing
- Juno v. Kite Case Implications For Functionally Claimed Biological Compositions
Solving The 4 Serialization Challenges Of Track & Trace In The Biopharma Industry
More than 10 years after introducing track and trace, the pharmaceutical industry still faces a number of technical challenges and limitations related to regulatory expectations, with many companies still transforming their packaging operations to meet them.
Demystifying Blockchain-Supported Smart Contracts
Promising increased accuracy, transparency, and security, smart contracts and blockchain technology are the next steps in the evolution of secure data transaction. Companies in the pharmaceutical industry, and their supply chains, will be forced to adapt their operations to keep up with these generational changes in order to competitively deliver services and treatments.
Juno v. Kite Case Implications For Functionally Claimed Biological Compositions
The Federal Circuit recently reversed a jury verdict in the case Juno Therapeutics, Inc. v. Kite Pharma, Inc.., wiping out a $1.2 billion judgment for Juno in the lower court by invalidating claims directed to the functional properties of biological compounds that could be used as therapies. What does this mean for biologics developers going forward?
Model-Based Control In Continuous Manufacturing of Biotherapeutics
During continuous processing, automated control techniques coupled with process analytical tools are required to monitor critical quality attributes and implement real-time control decisions to handle deviations. This article is the first in a two-part series examining how model-based control can be effectively implemented in the various unit operations.
Opportunities For Implantable Drug Delivery To Modernize Drug Therapy
The implantable drug delivery system allows targeted and localized drug delivery for achieving an optimum therapeutic effect. This article examines the clinical significance of implantable drug delivery systems as well as opportunities that can be leveraged by drug therapy developers in meeting global health needs, particularly in the areas of women's health, cancer treatment, and ocular disease treatment.
How To Mitigate The Risks Posed By "High-Risk" Host Cell Proteins
Host cell proteins are process‐related impurities that may copurify with biopharma drug products. Some of these can be considered high-risk, including those that are immunogenic, biologically active, or enzymatically active with the potential to degrade molecules or excipients used in formulation. Here's how to mitigate those risks.
Marks Took On FDA Vaccine Leadership Position – What Happens Now?
Center for Biologics Evaluation and Research Director Dr. Peter Marks decided to temporarily take on the leadership of the Office of Vaccine Research and Review after both its director, Marion Gruber, and deputy director, Philip Krause, unexpectedly announced in late August their decisions to exit the FDA.
Calculating The Process Capabilities Of Cleaning Processes: A Primer
The industry has begun the movement to science-, risk-, and statistics-based approaches to cleaning process development and validation. Process capability has become an important measure for demonstrating acceptable cleaning processe performance. Explore process capability, techniques used for its calculation, and how it's applied to cleaning processes.
PHARMA OUTSOURCING WHITE PAPERS
Process Characterization And Validation For Biologic Processes
Using a risk-based approach to generate an appropriate control strategy will help assure your product meets characterization and validation requirements, enabling timely approval and launch to market.
Process Characterization: Ready For The FDA?
Realizing the benefits of process characterization requires proper planning and application of a comprehensive process characterization strategy.
Rapid Change Is Everywhere In The Biotech Industry. Meaningful Innovation Is Not.
CDMOs face the challenge of integrating novel technologies to deliver cost-effective innovation to the market. How a CDMO responds to the unexpected can determine the success or failure of a project.
Multiplexing: Managing Risk With Proven, Single-Use Solutions
Instead of trying to make better predictions or erring on the side of overcapacity, developers and CDMOs should seek manufacturing flexibility.
Robust By Design — Overcoming The Biologics Challenge In Drug Delivery
The subcutaneous drug delivery route offers patients greater flexibility with home injections and provides considerable savings for healthcare systems. Autoinjectors used with pre-fillable syringes offer multiple benefits, from providing an accurate dosage to the reduction of needlestick injuries.
Three Options To Viral Vector Manufacturing Capacity
A recent Virtual Think Tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities, and how they can impact companies developing cell and gene therapies.